Recalls / Class III
Class IIID-304-2013
Product
Jevantique (norethindrone acetate and ethinyl estradiol) tablets; 1.0 mg/5.0 mcg, 90 count bottle (NDC# 52544-237-19), Rx only, Manufactured by Warner Chilcott Company, LLC, Fajardo, PR 00738, Distributed by Watson Pharma, Inc. Corona, CA 92880.
- Affected lot / code info
- Lot # 507694A; exp 02/13 Lot # 510041C; exp 05/13
Why it was recalled
Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the product due to migration from the cardboard cartons in which the product is packaged.
Recalling firm
- Firm
- Warner Chilcott Company LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Road 195, Km 1.1, Union Street, Fajardo, Puerto Rico 00738
Distribution
- Quantity
- 17,136 bottles
- Distribution pattern
- US Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2013-02-15
- FDA classified
- 2013-04-30
- Posted by FDA
- 2013-05-08
- Terminated
- 2014-06-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-304-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.